Planmeca Viso

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September 13, 2018 Planmeca Oy Lars Moring Regulatory Affairs Specialist Asentajankatu 6 FI-00880 Helsinki FINLAND Re: K181576 Trade/Device Name: Planmeca Viso Regulation Number: 21 CFR 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: August 15, 2018 Received: August 17, 2018 Dear Lars Moring: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. 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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jeff Rodgers Digitally signed by Jeffrey J. Ballyns -S DN· c=US o=US Government ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=20005697 25, cn=Jeffrey J. Ballyns -S Date: 2018.09.13 16:30:25 -04'00' for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K181576 Device Name Planmeca Viso Indications for Use (Describe) Planmeca Viso is a system intended to produce two-dimensional (2D) and three-dimensional (3D) digital x-ray images as well as three-dimensional (3D) optical images of the dento-maxillo-facial, cervical spine and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></rect> <path d="M2,2 L14,14 M14,2 L2,14" stroke="black" stroke-width="2"></path> </svg> </span> | |----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></rect> </svg> </span> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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SUBMITTER ### MANUFACTURER Planmeca Oy Asentajankatu 6 FI-00880 Helsinki, Finland Phone: +358 20 7795 500 Contact person: Lars Moring ## U.S. DESIGNATED AGENT Planmeca USA Inc. 100 North Gary Avenue, Suite A Roselle, IL 60172 Phone: (630) 894 2300 Contact person : Bob Pienkowski Date prepared: September 7, 2018 #### PRODUCT, CLASSIFICATION NAME II. Name of the device: Common or Usual Name: Classification name: Requlatory Class: Product Code: 510(k) number: Planmeca Viso Computed tomography x-ray system Computed tomography x-ray system (21 CFR 892.1750) -OAS #K181576 #### III. PREDICATE DEVICE Planmeca ProMax 3D Max #K160506 #### IV. REFERENCE DEVICE Planmeca ProMax 3D Mid #K103689 RAYSCAN A-EXPERT 3D, #K142247 ## V. DEVICE DESCRIPTION The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) images of the maxillofacial and ENT anatomies. Two dimensional (2D) images are produced with tomosynthesis method (panoramic) imaging) as well as conventional 2D radiography (cephalometric imaging, 2D views). In CBCT a cylindrical volume of data is captured in one imaging procedure. The data consists of several hundred sample images which are taken from different directions to cover a certain pre-programmed target area. These samples are used for 3D reconstruction (using a separate 3D reconstruction PC) that can be viewed in three dimensions using separate workstation and Planmeca Romexis software. ## VI. INDICATIONS FOR USE Planmeca Viso is a system intended to produce two-dimensional (2D) and three-dimensional (3D) digital x-ray images as well as three-dimensional (3D) optical images of the dento-maxillofacial, cervical spine and ENT (Ear, Nose, and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients. {4}------------------------------------------------ The Indications for Use (IFU) for the subject device are the same as those for the predicate device. ## VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE Both devices are 3D CBCT imaging system indicated for imaging dento-maxillofacial-, cervical spine- and ENT-regions and offer a variety of 3D fields of view suitable for each application. Both systems also provide 2D imaging capabilities, predicate device only for panoramic and Planmeca Viso both for panoramic and cephalometric imaging. Both systems are based on fixed anode X-ray tube and a flat panel detector of the same technology. Pixel sizes of the detector differ but voxel sizes on resulting 3D images are the same." Tube voltage range with Planmeca Viso is wider and ranges up to 120kV, providing users with option to utilize even higher X-ray penetration when necessary. | | Planmeca Viso | Predicate device Planmeca ProMax<br>3D Max | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | Planmeca Viso is a system intended to<br>produce two-dimensional (2D) and<br>three-dimensional (3D) digital x-ray<br>images as well as three-dimensional<br>(3D) optical images of the dento-<br>maxillo-facial, cervical spine and ENT<br>(Ear, Nose, and Throat) regions at the<br>direction of healthcare professionals as<br>diagnostic support for pediatric and<br>adult patients. | The Planmeca ProMax 3D Max or<br>Maximity is a system intended produce<br>two-dimensional (2D) and three-<br>dimensional (3D) digital X-ray images o<br>the dento-maxillo-facial, cervical spine<br>and ENT (Ear, Nose and Throat)<br>regions at the direction of healthcare<br>professionals as diagnostic support for<br>pediatric and adult patients. | | 3D Imaging | | | | Technical<br>characteristics | • CBCT (cone beam computed<br>tomography)<br>• 300 - 600 projections over 210° / 360°<br>rotation<br>• Reconstruction time 30 s - 6 min<br>• Voxel size 75-600µm | • CBCT (cone beam computed<br>tomography)<br>• 300 - 600 projections over 210° / 360°<br>rotation<br>• Reconstruction time 30 s - 6 min<br>• Voxel size 75-600µm | | Field Of View (FOV) | Ø30x30mm - Ø200x170mm (G5) /<br>Ø300x300mm (G7) | Ø42x48mm - Ø230x260mm | | 2D Imaging | | | | Technology | • SmartPan panoramic imaging,<br>tomosynthesis<br>• Multiview panoramic imaging,<br>tomosynthesis<br>• Cephalostat | • SmartPan panoramic imaging,<br>tomosynthesis<br>• Multiview panoramic imaging,<br>tomosynthesis<br>• No cephalostat | | Imaging system<br>performance<br>specifications | | | | X-ray detector | • Varex Imaging 16x16cm flat panel<br>(G5) / 25x30cm flat panel detector<br>(G7)<br>• aSi with Csl scintillator<br>• 127µm pixel pitch (G5) / 139µm pixel<br>pitch (G7)<br>• Bit depth 16bit<br>• Varian PaxScan 2530C<br>30.2(w)x24.9(h)cm<br>• GADOX scintillator | • Varex Imaging 25x20cm flat panel<br>detector<br>• aSi with Csl scintillator<br>• 127µm pixel pitch<br>• Bit depth 15bit | ### Table 1: Comparison with predicate device {5}------------------------------------------------ | X-ray tube and<br>generator | | | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | | • Fixed anode X-ray tube focal spot size 0.5 mm<br>• Tube voltage 60-120 kV<br>• Tube current 1-16 mA<br>• Exposure time 0.1–36 sec (pulsed) | • Fixed anode X-ray tube with 0.6mm focal spot<br>• Tube voltage 66-96 kV<br>• Tube current 1-12,5 mA<br>• Exposure time 3–24 sec (pulsed) | | Other | | | | Workflow | • Open positioning, doctor facing the patient<br>• Patient seated or standing | • Open positioning, doctor facing the patient<br>• Patient seated or standing | | Imaging Software | • Planmeca Romexis | • Planmeca Romexis | Cephalometric scanning feature and detector are identical to those in previously cleared reference devices. The PaxScan 2530C, used for cephalometric imaging in the subject device, was included as a cephalometric detector in a previously cleared 510(k) for the RAYSCAN a-Expert 3D (K142247). ## VIII. PERFORMANCE DATA Results from performance bench testing demonstrate that Planmeca Viso produces substantially equivalent image quality compared to the predicate and reference devices. ## IX. CONCLUSIONS The comparison of characteristics supports substantial equivalence. Planmeca Viso is as safe and effective as the predicate device.